Supplementary protection certificates in the system of the Unified Patent Court

The new European court system also provides for supplementary protection certificates, i.e., intellectual property rights which prolong the term of protection of the underlying (basic) patent for pharmaceutical and plant protection products in view of the fact that official marketing authorization is often tedious. 

The current practice

Irrespective of whether they are based on a national or European (basic) patent, the application for supplementary protection certificates has to be filed nationally with the national patent offices. The rejection of an application for the grant of a supplementary protection certificate can be appealed to national courts and litigation for enforcing as well as regarding the validity of a granted supplementary protection certificate is also conducted before national courts.

Jurisdiction of the Unified Patent Court over SPCs

Under Art. 30 of the Agreement on a Unified Patent Court (UPCA), the effect of a supplementary protection certificate equals that of a patent. Accordingly, Art. 32 UPCA stipulates the exclusive jurisdiction of the Unified Patent Court (UPC) over, inter alia, actions due to the infringement or for the declaration of invalidity of supplementary protection certificates. Thus, as soon as the UPC opens its doors, it will generally be exclusively competent for decisions regarding the infringement and validity of supplementary protection certificates based on a (European) (basic) patent – while during the transitional period national courts may also be seized instead of the UPCA (Art. 83(1) UPCA).

The examination of applications for supplementary protection certificates and their grant, however, will (initially) still solely be within the jurisdiction of the national bodies – even after the start of the UPC system.

That means, we will deal with a divided system in which the national patent offices are in charge of granting supplementary protection certificates, while legal disputes regarding granted supplementary protection certificates, i.e., infringement and validity proceedings, are also conducted before the UPC.

SPCs and the possibility of an opt-out

There is an exception to every rule! During the transition period (Art. 83 UPCA) there is still the possibility of having the infringement and validity of supplementary protection certificates based on European (basic) patents assessed solely by the national courts by opting out the European (basic) patent, or the supplementary protection certificates based on it, respectively, of the exclusive jurisdiction of the UPC.

There is no possibility of opting out a European (basic) patent and the supplementary protection certificates based on it from the UPC system independently of each other. In this respect, all supplementary protection certificates share the fate of the (basic) patent on which they are based. This applies to all combinations of different granting phases: If an opt-out was declared for the (basic) patent before supplementary protection certificates were granted, the opt-out automatically extends to the supplementary protection certificates upon grant. If supplementary protection certificates are already granted, the opt-out for the (basic) patent also extends to the supplementary protection certificates. Lastly, an opt-out can also be declared for European patents that have already expired in order to exclude the supplementary protection certificates from the exclusive competence of the UPC.

Since supplementary protection certificates are usually very valuable for the patent owner, it is to be expected that numerous (basic) patents will be opted out from the exclusive competence of the UPC in order to exclude the risk of central revocation of the (basic) patent. Therefore, it is possible that it will take several years until first decisions of the UPC in legal disputes regarding the infringement or validity of supplementary protection certificates will be rendered. However, the fact that owners of patents and supplementary protection certificates will have the possibility of influencing and shaping the development of UPC case law – especially at the beginning of the new court system – needs to be taken into consideration. Thus, it may be opportune to already review and decide which (basic) patents should be opted out from the new court system and which (basic) patents can potentially be used to help develop the case law of the UPC.

Unitary Patent as (basic) patent

Additionally, the questions arises whether future Unitary Patents can also serve as a (basic) patent for supplementary protection certificates.

This will be the case. For, under Art. 30 UPCA, a supplementary protection certificate has the same effects as a “patent” and Art. 2 lit. g UPCA defines “patent” as “a European patent and/or European patent with unitary effect”. Plus, Art. 1 lit. (c) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products as well as Art. 1 no. 9 of Regulation (EC) No 1610/96 concerning the creation of a supplementary protection certificate for plant protection products do not include any limitation to current European patents either.

While the UPC has exclusive competence for examining the infringement and validity of such a supplementary protective certificate based on a Unitary Patent as the (basic) patent, the national Patent Offices will (initially) still be competent for the grant of supplementary protection certificates based on Unitary Patents, since the UPCA lacks a provision in this respect.

Legal sources

Pursuant to Art. 24 UPCA, the UPC bases its decisions, inter alia, on EU law; therefore, in proceedings relating to the infringement and validity of supplementary protection certificates, it will also have to apply Regulations (EC) No 469/2009 and No 1610/96.

Same but different

While (initially) no differences will arise from the new court system regarding the grant of supplementary protection certificates, changes will arise – at least if no opt-out is declared for the (basic) patent and/or after the transition period has expired – regarding the enforcement of supplementary protection certificates insofar as the UPC will be competent instead of the national courts.

Supplementary protection certificate with unitary effect (uSPC)?

A supplementary protection certificate with unitary effect (uSPC) is currently not provided for in the Unified Patent Court system. However, in a “Study on the legal aspects of Supplementary Protection Certificates in the EU” on behalf of the European Commission, published on May 28, 20181, the Max Planck Institute concludes that introducing a unitary grant procedure for supplementary protection certificates seems reasonable. Subsequently, in March 2022, the European Commission suggested the introduction of a centralized system for the grant of supplementary protection certificates and issued a call for statements regarding a corresponding initiative2. What is conceivable in this respect is a unitary supplementary protection certificate (uSPC) or, at any rate, one single (“unitary”) procedure for the grant of a bundle of national supplementary protection certificates. European associations from the pharmaceutical sector have also advocated for the creation of a supplementary protection certificate with unitary effect in a joint position paper3

Hence, it remains to be seen whether a supplementary protection certificate with unitary effect will also be created in the future. Before this can happen, further details need to be clarified. For instance, the question which body will be competent for the grant. In this regard, the Max Planck Institute proposes a board of examiners from the national Patent Offices in the form of a “virtual office” or “virtual Unitary SPC Division”. But commissioning existing bodies of the EU or the EPA is also conceivable. In view of the costs associated to the current grant practice and the high administrative effort due to the grant on a national level, the creation of a unitary supplementary protection certificate as an actually logical addition to the European patent with unitary effect and to further harmonize European patent law does indeed seem desirable.

1) https://www.ip.mpg.de/en/research/research-news/study-on-supplementary-protection-certificates.html
2) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13353-Medicinal-plant-protection-products-single-procedure-for-the-granting-of-SPCs_en 
3) https://www.efpia.eu/media/15414/ecpa-efpia-and-ifah-europe-joint-position-paper-proposal-for-a-unitary-spc-july-2015.pdf 

 

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Nadine Westermeyer
Attorney-at-Law (Rechtsanwältin), Partner*

Nadine Westermeyer